Kornimate/medical-research-clean huggingface dataset:
closed loop vagal nerve stimulation for patients with posttraumatic stress disorder

Conditions: PostTraumatic Stress Disorder

Summary: the tasks of the project are to map the potency and kinetics of the neurologic, autonomic peripheral, inflammatory, and behavioral responses to vagal nerve stimulation (vns) vs. sham treatment, at baseline and in response to stressful traumatic scripts related to personal traumatic events, as well as a series of other stressors.

the purpose of this project is to develop the fundamental physiological understanding of feedback controlled vagal nerve stimulation (vns) using positron emission tomography (pet) brain imaging and blood biomarker measurement with stress in healthy individuals and individuals with ptsd. healthy human subjects with a history of psychological trauma but without the diagnosis of a psychiatric disorder (phase 1), and human subjects with a history of ptsd (phase 2), undergo pet imaging of the brain in conjunction with vns or a sham treatment during exposure to neutral scripts and scripts of personal traumatic events. blood is drawn simultaneously for measurement of a variety of stress responsive biomarkers, including inflammatory markers and neurohormones. a second pet scan with biomarkers assesses the delayed effects of vns. on two other days subjects undergo exposure to random stressors with vns or sham in conjunction with measurement of stress biomarkers.

Eligibility criteria:
inclusion criteria: phase 1: * do not meet criteria for post traumatic stress disorder (ptsd) or other major mental disorder as determined by the structured clinical interview for diagnostic and statistical manual of mental disorders-5 (dsm-5 scid) interview for ptsd * have a history of psychological trauma as defined by dsm-5. phase 2: - meet criteria for ptsd as determined by the structured clinical interview for dsm-5 (scid) interview for ptsd. exclusion criteria: * positive pregnancy test * meningitis * traumatic brain injury * neurological disorder or organic mental disorder * history of loss of consciousness greater than one minute * alcohol abuse or substance abuse or dependence based on the scid within the past 12 months * positive toxicology screen * current or lifetime history of schizophrenia, schizoaffective disorder, or bulimia, based on the scid * a history of serious medical or neurological illness, such as cardiovascular, gastrointestinal, hepatic, renal, neurologic or other systemic illness * evidence of a major medical or neurological illness on physical examination or as a result of laboratory studies (complete blood count (cbc), blood urea nitrogen (bun), creatinine, blood sugar, electrolytes, liver and thyroid function tests, urinalysis, and ekg) * active implantable device (i.e. pacemaker) * carotid atherosclerosis * cervical vagotomy

Keywords: stress disorders, post-traumatic posttraumatic stress disorder ptsd vagal nerve
doppler ultrasound assisted varicocelectomy improve sperm qualities

Conditions: Varicocele

Summary: to evaluate the benefits of laparoscopic doppler ultrasound (ldu) assisted laparoscopic varicocelectomy (lv) and compare the surgical outcomes and complications between ldu assisted lv (ldu-lv) and microscopic subinguinal varicocelectomy for infertile patients with varicoceles.

to compare the surgical outcomes such as semen parameters and the pregnancy rate and complications like postoperative varicocele recurrence and hydrocele between laparoscopic doppler ultrasound assisted laparoscopic varicocelectomy and conventional microscopic subinguinal for infertile patients with varicoceles. to examine the microanatomy of the spermatic cord within suprainguinal portion.

Eligibility criteria:
inclusion criteria: 1. 20-39 years old who had infertility for more than 1 year and had clinical palpable varicoceles; 2. impaired semen quality including sperm concentration \<15 million/ml or total motility \<40% or progressively motile \< 32% (a+b), the 5th edited world health organization criteria was referred; 3. with normal level of serum hormones including follicle stimulating hormone, luteinizing hormone, thyroid hormones and prolactin; 4. patient's spouse was healthy in reproduction. exclusion criteria: 1. with subclinical varicocele, recurrent varicoceles; 2. normal semen analyses; 3. other reasons of infertility than varicoceles; 4. refusing to enter randomization; 5. female partner older than 35 years; 6. with abnormal level of serum hormones; 7. female factor infertility; 8. with significant surgical diseases, congenital diseases or endocrine diseases.

Keywords: doppler ultrasound laparoscopic microscopic subinguinal varicocelectomy
biomechanical effects of wearing a sacroiliac belt in women

Conditions: Pelvic Girdle Pain

Summary: women with pelvic girdle pain pgp) often get relief from using a sacroiliac belt. the study will explore if there are differences and in the changes of lower body movement in stability with the belt on and with the belt off. women with pgp will be matched with women without to explore if there is a difference between these two groups. this will be looked at in standing and in walking.

sacroiliac (si) joint dysfunction (also called pelvic girdle pain) has been associated with impaired load transfer across the lumbopelvic region. this can result in lower back pain as well as poor biomechanical adaptation during walking. sacroiliac (si) belts have typically been prescribed in order to mitigate pain and improve load transfer in individuals with si joint dysfunction. it has been speculated that si belts have the ability to instantaneously increase joint stability, and as a result improve load transfer and muscle activation and recruitment. however, this speculation is primarily based on anecdotal evidence; there is little biomechanical research supporting the effects of wearing an si belt. in order to gain an improved understanding of the biomechanical effects of wearing an si belt, the investigators propose to conduct a study with the following key objectives: 1. determine if there are differences with respect to neuromuscular, kinematic, or pressure patterns during walking and/or standing between healthy stable individuals and individuals with si joint dysfunction 2. determine if wearing an si belt affects neuromuscular, kinematic, or pressure patterns during walking and/or standing in women with sacroiliac instability variables measured will include: 1. kinematics will be collected to quantify posture and joint angles 2. kinetics will be collected to quantify ground reaction forces 3. plantar pressure will be collected to quantify force distribution and center or pressure 4. joint moments (lumbar-pelvic and hip) will be added as variables. the investigators will use inverse dynamics to calculate various joint moments during walking.

Eligibility criteria:
inclusion criteria: * females * individuals with isolated si joint dysfunction * individuals with shoe size 6, 7, 8 or 9 us and matched controls by age (within 5 years), bmi (within one point) and parity exclusion criteria: * pregnancy in the last year or presently pregnant * significant lumbar dysfunction * significant hip dysfunction * leg length discrepancy of 1 cm or more * women who have previously undergone prolotherapy or si joint injections * women with previous lower back, hip, knee or ankle surgery * inability to stand for 60 sec unaided or to walk unaided.

Keywords: sacroiliac belt kinematics stability pelvic girdle pain sacroiliac instability
postoperative pain and sirs after preoperative analgesia with clonidine or levobupivacaine

Conditions: Analgesia; Pain; Systemic Inflammatory Stress Response

Summary: the purpose of this study was to investigate hypothesis that preoperative administration of epidural clonidine will reduce postoperative pain and systemic inflammatory stress response better than epidural levobupivacaine.

investigations showed that upregulation of prostaglandin e2 and interleukin-6 at central sites is an important component of surgery induced inflammatory response in patients. postoperative period is associated with an increased production of cytokines, which augment pain sensitivity. with adequate perioperative pain control it is possible to control central and peripheral inflammatory response to surgery, and influence on patient outcomes. use of analgetics before the pain stimulus (preventive analgesia) prevent development of neuroplastic changes in central nervous system, and reduces pain. clonidine is an alpha2-adrenergic agonist with sedative, analgesic and hemodynamic properties. it inhibits transmission of nociceptive stimuli in the dorsal horn of the spinal cord, acting on the inhibitory descending pathways. according to recent experimental investigations clonidine lowers proinflammatory cytokine level, and prevents hypersensitization acting through adrenoreceptors alpha-2a. levobupivacaine is a long-acting local anesthetic, s-enantiomer of bupivacaine, with identical anesthetic potency. when administered intraperitoneally or by local infiltration of operation site, levobupivacaine produced analgesia and reduction of proinflammatory cytokines. investigations of epidural and intrathecal levobupivacaine provide evidence for improved postoperative analgesia with reduced analgesic consumption. but, it remains unknown if that analgesia is sufficient enough to blockade inflammatory stress response during perioperative time.we want to investigate and compare analgesic and immunomodulation efficacy of this two frequently used analgesics.

Eligibility criteria:
inclusion criteria: * colorectal resection surgery patients * preoperative risk of anesthesia and operation, asa (american society of anesthesiologists) physical status i or ii exclusion criteria: * diabetes mellitus * renal insufficiency * liver insufficiency * autoimmune disease * corticosteroid and immunosuppressive use * operation time exceeding six hours

Keywords: clonidine levobupivacaine preoperative analgesia postoperative pain systemic inflammatory stress response epidural analgesia anesthetics, local
effect of hyaluronic acid ecm on venous ulcers

Conditions: Venous Ulcers

Summary: the purpose of this pilot study is to compare the incidence and rate of wound healing in subjects with venous ulcers treated with an extracellular matrix composed of hyaluronic acid plus compression therapy as compared to standard care. the study also intends to follow the subjects for a 16-week period in order to evaluate ulcer recurrence within treatment groups.


Eligibility criteria:
inclusion criteria: 1. male and female patients 18-85 years of age with chronic venous insufficiency (cvi) and the presence of venous ulceration for longer than 2 months 2. subject and/or caregiver must be willing and able to tolerate multi-layered compression bandages 3. study subject must be reliable, responsible and able to visit the clinic weekly for the full 16 week period. exclusion criteria: 1. ulcers of non-venous etiology 2. subject has a known sensitivity to hyaluronic acid 3. presence of wound infection as determined by clinical signs and symptoms 4. subject has any evidence of peripheral arterial disease (pad) 5. subject has received growth factor therapy (e.g., autologous platelet-rich plasma gel, becaplermin, bilayered cell therapy, dermal substitute, extracellular matrix) within two weeks of screening date. 6. pregnancy or lactation at time of treatment. 7. subject is currently receiving or has received radiation or chemotherapy within 3 months of randomization. 8. subject currently enrolled or participated within 30 days of baseline in another investigational device, drug or biological trial. 9. history of alcohol or drug abuse. 10. subject allergic to a broad spectrum of primary \& secondary dressing materials, including occlusive dressings and the adhesives on such dressings.
the diabetes patient takes responsibility

Conditions: Diabetes Mellitus, Type 1; Patient Reported Outcome; Health Care Economics and Organizations

Summary: people with type 1 diabetes (t1d) are randomized to follow the normal scheduled visit procedure in the outpatient clinic or to have open access to the clinic, i.e. they can get an appointment with a nurse or doctor within defined time intervals via telephone, e-mail or apps. patient-reported outcomes (patient satisfaction and experience, qol) clinical variables (hba1c, blood pressure etc.) and use of human resources (doctors, diabetes-nurses and diet physicians) are monitored.

this is a 24 month prospective randomized controlled trial. people with type 1 diabetes (t1d) are randomized to two groups: (i) patients randomized to the control group receive their standard diabetes care and are seen in the out-patient clinic with regular intervals (typically a diabetes nurse every 3-4 month and a diabetes doctor once a year. (ii) patients randomized to the intervention group are not called for at fixed time points. they can arrange visits in the diabetes clinic whenever they feel the need to do so. the have a guarantee for a consultation with a diabetes nurse within one week and with a diabetes doctor or diet physician within two weeks. questionnaires (a specific questionnaire focused on patient satisfaction developed for the study and addqol) are filled in at time 0 and 24 month. blood samples for diabetes-related variables (hba1c, lipid status), blood pressure, body weight etc. are likewise recorded at time 0 and 24 month. economic and time requirements are evaluated at 24 month.

Eligibility criteria:
inclusion criteria: type 1 diabetes 18 - 80 years multiple injections or insulin pump therapy exclusion criteria: newly diagnosed t1d psychiatric illness need for translation unstable conditions such as progressive retinopathy

Keywords: diabetes organization out-patient control
effectiveness of lemon essential oil of aromatherapy in reducing test anxiety in nursing students

Conditions: Nursing Student

Summary: this study examines the effectiveness of lemon essential oil in reducing test anxiety in first-year nursing students.

while studies on the role of aromatherapy in reducing test anxiety exist, those evaluating the effects of lemon essential oil on test anxiety are extremely limited. in this study, the effect of a different aromatherapy application on reducing test anxiety was tried to be determined by using lemon essential oil. it is envisaged to provide an alternative aromatherapy application to students and educators to reduce test anxiety through the results obtained in the study.

Eligibility criteria:
inclusion criteria: * no respiratory system diseases (asthma, flu etc.) * no allergy to any smell, no pregnancy status, * absence of epilepsy discomfort, * not having a condition that prevents smell, not using any medication that will affect heart rate and blood pressure, exclusion criteria * any respiratory system disease (asthma, flu, etc.). * have a known allergic response to essential oil to be used, * lack of smell, use of any medication affecting heart rate and blood pressure, * to use other complementary medicine practices

Keywords: lemon essential oil test anxiety, student nurse
prevention of acute radiation enteritis with glutamine

Conditions: Acute Radiation Enteritis

Summary: ionizing radiation has cytotoxic effects, and is commonly used as treatment for neoplasm. a common adverse effect of radiation is acute diarrhoea. glutamine is an aminoacid with antioxidant effects that can protect tissues of damage dued to radiation. the investigators designed a randomized, double-blind trial phase iii to study if glutamine prevents acute radiation enteritis.


Eligibility criteria:
inclusion criteria: * age \> 18 yr * gynaecological,prostatic, rectal or other abdominal cancer * radiotherapy with/without chemotherapy exclusion criteria: * life expectancy \< 1 yr * age \< 18 yr * gut diseases: inflammatory bowel disease,sprue, irritable bowel disease... * moderate to severe chronic renal failure * hepatic cirrhosis

Keywords: radiotherapy diarrhoea glutamine oxydative stress calprotectin citrulline
comparative effectiveness of direct admission & admission through emergency departments for children

Conditions: Hospitalization; Child Health

Summary: at a national level, emergency departments (eds) serve as the portal of hospital admission for 75% of hospitalized children. the remainder occur via direct admission, defined as admission to hospital without first receiving care in the hospital's ed. the overall goals of this research are to: (i) implement pediatric direct admission systems at 3 hospitals, (ii) compare the timeliness of healthcare delivery for children who are admitted directly and through emergency departments, (iii) determine which patient populations achieve the greatest benefits from direct admission, and (iv) identify barriers and facilitators of successful implementation.

the specific aims of this research are to: (i) determine the effect of a pediatric direct admission system on timeliness of healthcare provision (the investigator's primary outcome), family experience of care, and rates of clinical deterioration compared to hospital admission beginning in the ed; (ii) identify the pediatric populations and conditions that experience the greatest benefits from direct admission; and (iii) through interviews with key informants, identify barriers to and facilitators of implementing standardized direct admission processes. to achieve these aims, a stepped-wedge cluster randomized controlled trial at three geographically diverse hospitals in the united states will be conducted, randomizing primary and urgent care practices in the hospitals' catchment area to cross over to the direct admission intervention at four time points. linear models with random effects for clusters and time period fixed effects will be used to evaluate outcomes associated with the direct admission intervention. to examine for heterogeneity of treatment effects, interactions between direct admission and a priori-specified subgroups will be examined.

Eligibility criteria:
inclusion criteria child has one of the following presenting diagnoses: * gastroenteritis * dehydration * skin and soft tissue infection * urinary tract infection/pyelonephritis * pneumonia * viral infection not otherwise specified * influenza exclusion criteria ineligible children include those: * with planned admissions (i.e., chemotherapy) * admitted to non-pediatric hospital medicine services (i.e., intensive care) * transferred from other hospitals
leucine supplementation in sarcopenic older individuals

Conditions: Frail Elderly Syndrome; Sarcopenia

Summary: caring with older people in west societies has becoming a challenge for all health professional and any measure that can increase health or well-being will be ultimately improve quality of life and life expectancy. frailty is a geriatric syndrome describing physical and functional decline that occurs as a consequence of certain diseases (e.g., cancer, chronic infection, etc.) but also even without disease. frailty is characterized by an increased risk for poor outcomes such as incident falls, fractures, disability, comorbidity, health care expenditure and premature mortality. the aetiology of frailty is not well understood but it has been associated with changes in several physiologic systems, including inflammation, metabolic and micronutrients deficits. the investigators wish to test with a confident perspective that any measured that improve the efficiency of muscular system can prevent the progression of frailty syndrome and that can have many others effects since it has been consistently demonstrated that a proper muscular function in aging is associated with other signs and symptoms. looking at the literature, there are two clinical trials that evaluated the effect of leucine supplementation in older individuals with beneficial effects. the investigators wish to replicate those findings and to extend the analysis of the effect afforded by leucine supplementation in sarcopenia, frailty and cognitive function in individuals living in nursing homes in valencia and province. this trial will show the eventual effects of leucine supplementation in elderly people may be also useful to afford some beneficial effects (sleep, cognitive function, depressed mood, balance and gait, etc) by modulating the function of muscular and metabolic system and in reduce the progression of sarcopenia and loss of muscular function.


Eligibility criteria:
inclusion criteria: * ability to walk alone or with help of a can or a walker * age 60 years or older * cognitive function equal or higher than 21points in mini-mental examination score * both genders * institutionalized in nursing homes for at least 6 months exclusion criteria: * clinical diagnosed severe dementia * severe psychiatric disease (i.e. schizophrenia) * glomerular filtrate \<30 ml/min/1,73m2

Keywords: frailty aged leucine sarcopenia
computer assisted lessening of intrusive memories in the emergency department

Conditions: Post Traumatic Stress Disorder

Summary: during the covid-19 pandemic, clinical staff working in frontline nhs hospital and pre-hospital departments (e.g. emergency department, intensive care unit, ambulance service) are being faced with difficult and stressful situations, which may be traumatic to them. staff report high rates of post-traumatic stress symptoms, such as intrusive memories of these incidents, which 'pop into their mind' unexpectedly, are distressing and can impact on work performance. currently there is a lack of tailored evidence-based interventions for staff struggling with intrusive memories of work-related traumatic events: simple, accessible, remotely-delivered interventions are needed. an intervention which has been found to be effective in reducing intrusive memories is a simple cognitive task that involves briefly bringing to mind the memory and then playing the computer game tetris with specific ("mental rotation") instructions. this case series study aims to test the intervention in a group of 8-20 staff members working clinically in nhs hospital and pre-hospital departments. the intervention will be delivered remotely (via computer/smartphone/tablet/phone). participants will record the number of intrusive memories daily over a 3-week period, with the intervention delivered after 1 week (with optional subsequent booster sessions). symptoms of trauma, anxiety and depression will be assessed weekly over this period, and at 4 weeks after the intervention. it is predicted that participants will have fewer intrusive memories per day/week, and lower clinical symptoms scores, after completing the intervention than before completing the intervention. the study will also investigate how feasible and acceptable the intervention is for nhs staff. findings will inform the next steps in developing and evaluating a digital intervention to reduce intrusive memories of work-related traumatic events in healthcare staff.


Eligibility criteria:
inclusion criteria: * aged 18 or above; * able to read, write and speak in english; * able and willing to provide informed consent and complete study procedures; * nhs hospital and pre-hospital clinical staff; experiencing intrusive memories, which are problematic to them (self-report); * reporting the occurrence of at least two intrusive memories of a work-related traumatic incident in the week prior to beginning the study; * able and willing to talk about the intrusive memories; * able and willing to complete an electronic intrusion diary over a 2-3 week period; * able and willing to play tetris on a hand-held device; * not currently undergoing treatment for ptsd or its symptoms. exclusion criteria: * participants will be excluded if they have fewer than two targeted intrusive memories per week during the pre-intervention period; * participants will be also excluded if they start undergoing treatment for ptsd or its symptoms during the course of the study.